Birth of Korea's Fifth Digital Therapeutic
'SoriClear' Approved as the First Domestic Digital Therapeutic for Tinnitus
NewLive announced on the 12th that its digital therapeutic(DTx) 'SoriClear' has obtained domestic approval as the fifth digital therapeutic product from the Ministry of Food and Drug Safety. It is the first digital therapeutic in Korea aimed at treating tinnitus.
SoriClear quantifies factors such as the patient's age, gender, tinnitus frequency, and intensity, then uses artificial intelligence (AI) to predict the patient's disability factors and treatment targets, providing a customized tinnitus treatment program tailored to the patient. It is a hospital-use digital therapeutic, allowing medical staff to download the application (app) and use it for patients.
Song Jae-jun, CEO of NewLive (Professor of Otorhinolaryngology-Head and Neck Surgery at Korea University Guro Hospital), explained, "Mental and physical functional impairments caused by tinnitus cause significant suffering to patients, but there is no clear treatment method. Through this product approval, we can provide a more precise personalized treatment solution for tinnitus and offer new treatment options to patients struggling with tinnitus."
Previously, NewLive's electronic medicine 'SoriCle' recently received product approval in Brazil, enabling the company to target the South American market centered on Brazil. Electronic medicine is a device that treats diseases by stimulating the brain. SoriCle treats by electrically stimulating the ear area (auricular branch) connected to the vagus nerve, which regulates the autonomic nervous system, using headphone equipment worn on both ears. The AI-controlled electrical stimulation increases cerebral blood flow and neurotransmitters, calming the auditory cortex excitation that causes tinnitus.
Established in August 2018 as a subsidiary of Korea University Medical Technology Holdings, NewLive is developing digital therapeutics based on electronic medicine medical devices and software utilizing non-invasive vagus nerve stimulation (Non-invasive VNS) technology, which is gaining global attention for degenerative brain diseases.
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